BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SWEDEN & MARTINA INC

    Reg #: 3011276344 · FEI: 3011276344 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    404
    Establishment Types
    1
    Classifications
    28

    Registration Details

    Registration Name
    SWEDEN & MARTINA INC
    Registration Number
    3011276344
    FEI Number
    3011276344
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    916 SPINDLETREE AVENUE
    City
    Naperville
    State
    IL
    ZIP
    60565
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130235

    Owner / Operator

    Firm Name
    Sweden & Martina INC
    Operator Number
    10048147
    Address
    916 SPINDLETREE AVENUE
    City
    Naperville
    State
    IL
    Postal Code
    60565
    Country
    US
    Correspondent
    Alessia Pezzato

    Products

    Device Name Product Code
    Bone Grafting Material, Human Source NUN
    Bone Grafting Material, Animal Source NPM
    Implant, Endosseous, Root-Form DZE
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Suture, Absorbable, Natural GAL
    Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Suture, Nonabsorbable, Silk GAP
    Bone Grafting Material, Synthetic LYC
    Barrier, Animal Source, Intraoral NPL
    Chisel (Osteotome) KDG
    Gutta-Percha EKM
    Restoration, Resin NSM
    System, Image Processing, Radiological LLZ
    Barrier, Synthetic, Intraoral NPK
    Remover, Crown EIS
    Abutment, Implant, Dental, Endosseous NHA
    Handpiece, Rotary Bone Cutting KMW
    Accessories, Implant, Dental, Endosseous NDP
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Motor, Surgical Instrument, Ac-Powered GEY
    Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene NBY
    Wound Dressing With Animal-Derived Material(S) KGN
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Restoration, Resin, Crown And Bridge NSN
    Drill, Dental, Intraoral DZA
    Handpiece, Direct Drive, Ac-Powered EKX

    Proprietary Names

    BONE GRAFTING MATERIAL, HUMAN BONE GRAFTING MATERIAL IN DELIVERY APPLICATOR PREMIUM ONE Sutures ECLIPSE OSSIX PLUS CHISEL (OSTEOTOME) GUTTA-PERCHA POINTS FULL BODY POST BRIDGE 12 ELEMENTS ARCHIPLAN SOFTWARE DESIGN ARCHIPLAN ARCHIPLAN SOFTWARE PRO REAL GUIDE ARCHIPLAN SOFTWARE CAD OPEN TEX Bone Grafting Material COLLAGEN DENTAL MEMBRANE REMOVER, CROWN MILLABLE TITANIUM ABUTMENT MILLABLE TITANIUM SLEEVE NEOMEM FLEX PLUS Volumax CONTRAANGLE FOR SURGERY 20:1 CONTRAANGLE FOR SURGERY 1:1 REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 8.5 MM SUPPLEMENTARY DRILLS SET LONG DRILL DIAM. 4,25 MM REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 13 MM LONG DRILL DIAM. 3,60 MM REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 11.5 MM TRANSFER P.A.D. FOR CAD-CAM STOP H.8 MM FOR DRILL TRANSFER 3.30 PR/SH SHORT DRILL DIAM. 2,00 MM SHORT STOP H. 8,5, D. 5,50 MM ROUND TIP OSTEOTOME FOR SHELTA KIT D.B.E. SYSTEM REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 13 MM PREMIUM BONE PROFILER LONG DRILL DIAM. 3,30 MM PREMIUM SURGICAL KIT ECHOPLAN COUNTERSINK DRILL PARALLELISM PIN WITH DEPTH LONG STOP H. 15, D. 4,15 MM STOP H.6 MM FOR DRILL INSTRUMENTS TRAY FOR REPLY FOR SHELTA IMPLANT D. 50 MM, L. 11.5 MM STOP H.7 MM FOR DRILL UNIVERSAL INITIAL MUCOTOME SURGICAL KIT FOR PRAMA SURGICAL KIT FOR PRE/KOH IMPLANT SYSTEM SURGICAL KIT ONEBOX FOR PREMIUM IMPLANT SYSTEM CHAMFERED DRILL D. 30 MM ABUTMENT ECHO PREMIUM-KOHNO COUNTERSINK DRILL D.4.10 MM STOP FOR CONICAL DRILL REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 10 MM SHORT STOP H. 10, D. 4,15 MM PRE-MADE REP. ABUT STRAIGHT X-RAY TEMPLATES LONG DRILL DIAM. 2,50 MM PRECISION DRILL REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 15 MM REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 15 MM REPLY FOR SHELTA IMPLANT D. 50 MM, L. 8.5 MM SURGICAL KIT "ONEBOX" SHORT STOP H. 8,5, D. 4,15 MM FINAL CONICAL DRILL GLOBAL PERI-SET , KIT FOR SURGICAL TRANSFER ECHO FOR GLOBAL M.I.S.E. EVO KIT LONG SCREW DRIVER FOR LOCATOR SURGICAL KIT FOR GLOBAL IMPLANT SYSTEM FINAL CONICAL DRILL SHELTA O-RING KIT FOR INSTRUMENTS ABUTMENT ECHO KOHNO ABUTMENT ECHO GLOBAL FLAT TIP OSTEOTOME FOR SHELTA STOP H.4 MM FOR DRILL COUNTERSINK FOR PREMIUM SP INTERMEDIATE DRILL HAND DRIVER FOR ABUTMENT LONG SURGIC. HAND SCREWDRIVER CYLINDRICAL FINAL DRILL STOP H.2 MM FOR DRILL NON RETENT. LONG HAND DRIVER REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 13 MM RIGHT ANGLE RETENTIVE DRIVER PULL-UP TRANSFER REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 10 MM TITANIUM SLEEVE UNIVERSAL BONE PROFILER BONE TAP PREMIUM D. 3,80 MM REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 15 MM INTRAORAL SCANBODY TEMPORARY ABUTMENT REMOVAL SCREW KIT FOR GLOBAL LONG DRILL DIAM. 3,40 MM REMOVAL SCREW KIT FOR PRE/KOH CSR STOP FOR CYLINDRICAL DRILL TAPERED FINAL DRILL REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 11.5 MM SHORTY DRILLING KIT STOP H.9 MM FOR DRILL LONG DRILL DIAM. 2,00 MM SURGICAL KIT FOR SHELTA IMPLANT SYSTEM STOP H.3 MM FOR DRILL CLOSED TRAY TRANSFER SURGICAL KIT ECHOPLAN PRO REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 15 MM PEEK CAP FOR PREMADE POST GLOBAL BONE EXPANDER KIT SHORT SCREW DRIVER FOR LOCATOR DEPTH GAUGE HOLE IMPLANTS PARALLEL PIN ABUTMENT ECHO OUTLINK2 POST SCREW FOR PRAMA IMPLANT ROUND TIP OSTEOTOME FOR GLOBAL SURGICAL SLEEVE WITH HEX.DIAM. NON RETENTIVE DIGITAL DRIVER STOP FOR CYLINDRICAL DRILL INSTRUMENT TRAY ECHOPLAN BONE TAP PREMIUM SP D.3,80 MM REMOVAL SCREW KIT FOR OUTLINK2 MOUNTER OUTLINK2 D. 3,30 MM TI POST ANATOMICAL FINAL CONICAL DRILL SYRA SHORT STOP FOR CONICAL SYRA SHORT PICK-UP TRANSFER FOR PRAMA CASTABLE POST,NON REP., GOLD BONE TAP PREMIUM D. 4,25 MM TEFLON CAP BALL ATTACHMENTS PRE-MADE REP. ABUT ANATOMICAL REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 11.5 MM SHORT DRILL DIAM. 2,90 MM DOUBLE MOUNTER STOP KEY FOR REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 13 MM RETENT.SHORT R.A. EASY INSERT ABUTMENT SCREW M1.8 SHORT DRILL DIAM. 3,80 MM REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 10 MM RETENT.EASY INSERT HAND DRIVER TRANSFER 50 PR/SH REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 8.5 MM HAND BONE TAP FOR GLOBAL LONG DIGITAL RETENTIVE DRIVER REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 8.5 MM X-RAY TEMPLATES FOR PRAMA AND SCANBODY iNTRAORAL ANALOGUE FOR ABUTMENT CYLINDRICAL PILOT DRILL PILOT DRILL HAND BONE TAP FOR KOHNO BONE TAP PREMIUM D. 5,00 MM LONG DRILL DIAM. 3,20 MM BONE PROFILER SLEEVE SHORT PROSTHETIC HAND SURGICAL SLEEVE DIAM. 5,50 MM REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 13 MM SHORT DRILL DIAM. 4,25 MM SURGICAL KIT ECHOPLAN SUPPLEMENTARY KIT PREMIUM SHORT SURGIC. HAND SCREWDRIVER SILICONE SUPPORT FOR SURGICAL STOP H.10 MM FOR DRILL SHORT DRILL DIAM. 3,30 MM SHORT DRILL DIAM. 3,20 MM OUTLINK2 SUPPLEMENTARY INSTR. BONE EXPANDER FOR D.B.E REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 8.5 MM TRY-IN KIT FOR PREMIUM RETENT.LONG R.A. EASY INSERT CONCAVE TIP OSTEOTOME D.2.40 HEXAGONAL SCREWDRIVER FOR HAND DRIVER FOR R.A. INSTRUM. HOLDER FOR PREMIUM SP SHORT STOP H. 10, D. 5,50 MM BONE TAP PRE/OUT D. 3,30 MM HAND SCREWDRIVER FOR BALL EXTENSION FOR SURGICAL DRILLS EXTRA LONG PROSTHETIC HAND REPLY FOR GLOBAL IMPLANT HAND DRIVER FOR TITANIUM CAP TRANSFER ECHO FOR PREMIUM MOUNTER WITH SCREW FOR PRE/KOH SURGICAL HAND SCREWDRIVER FOR SHORT DIGITAL RETENT. DRIVER LONG STOP H. 13, D. 5,50 MM TORQUE CONTROLLED RATCHET KIT SHORT STOP H. 11,5, D. 4,15 MM STOP H.5 MM FOR DRILL SHORT DRILL DIAM. 2,50 MM SHORT DRILL DIAM. 4,00 MM PILOT DRILL GLOBAL NON RETENT. SHORT HAND DRIVER CARRIER FOR ANGLED ABUTMENT PRE/KOH BONE PROFILER "SURGICAL KIT ""ONEBOX2""" ABUTMENT ECHO PREMIUM REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 8.5 MM LONG DRILL DIAM. 2,80 MM REPLY FOR SHELTA IMPLANT PINS DRILL HAND BONE TAP FOR PRE/KOH SURGICAL KIT FOR PREMIUM IMPLANT SYSTEM INITIAL DRILL BUILT-IN STOP XS SURGICAL HAND SCREWDRIVER SHORT DRILL DIAM. 2,80 MM LONG DRILL DIAM. 3,00 MM EXTENSION FOR HAND SCREWDRIVER REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 8.5 MM LONG DRIVER FOR GLOBAL IMPL. MOUNTER OUTLINK2 D. 4,10 MM RIGHT ANGLE SCREWDRIVER FOR REPLIES FOR SHELTA IMPLANTS SUPPLEMENTARY KIT OUTLINK2 REPLY FOR SHELTA IMPLANT D. 50 MM, L. 10 MM RIGHT ANGLE CONNECTOR REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 10 MM CASTABLE POST,NON REP., CR-CO HAND BONE TAP FOR PREMIUM "SURGICAL KIT ""ONEBOX""" SHORT DRILL DIAM. 3,60 MM SHORT HAND BONE TAP BONE TAP FOR OUTLINK2 TRANSFER ECHO FOR PRE-KOH TG FINAL CYLINDRICAL DRILL ABUTMENT SCREW M 2 LONG STOP H. 15, D. 5,50 MM EXTRA SHORT SURGICAL HAND SHORT STOP H. 7, D. 5,50 MM ROUNDED DRILL D. 3.40 MM TRANSFER ECHO FOR OUTLINK2 BRUSH SURGICAL SLEEVE DIAM. 4,15 MM DOUBLE TIP PLUGGER REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 11.5 MM REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 15 MM GLOBAL BONE PROFILER REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 10 MM ROUND TIP OSTEOTOME D.20 STOP H.1 MM FOR DRILL REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 10 MM SHORT DRILL DIAM. 3,40 MM MOUNTER PRAMA, FOR SLEEVE CONCAVE TIP OSTEOTOME D.1.60 REPLY FOR SHELTA IMPLANT D. 50 MM, L. 15 MM SURGICAL KIT ONEBOX2 FOR OUTLINK2 IMPLANT SYSTEM COUNTERSINK FOR OUTLINK2 REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 11.5 MM INITIAL DRILL D. 20 MM SILICONE SUPPORT FOR SCREWKIT REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 11.5 MM RIGHT ANGLE DRIVER FOR GLOBAL- TEFLON CAP CONTAINER FOR BALL PREMIUM SUPPLEMENTARY INSTR. SURGICAL KIT "ONEBOX2" OUTLINK2 SURGICAL KIT ECHOPLAN RIGHT ANGLE BONE TAP SUPPLEMENTARY INSTRUM. SET LONG DRILL DIAM. 4,00 MM INTERMEDIATE DRILL GLOBAL MOUNTER STOP KEY FOR STOP H.11 MM FOR DRILL SPARE CAST. SLEEVE FOR GOLD RIGHT ANGLE SCREWDRIVER BREAK UP DRILL D. 30 MM INTERMEDIATE DRILL D. 2.50 MM MOUNTER TRAY ORGANIZER SURGICAL KIT FOR OUTLINK2 IMPLANT SYSTEM CASTABLE CAP FOR PREMADE ABUT TORQUE WRENCH WITH LEVER SHORT STOP H. 11,5, D. 5,50 MM TRANSFER 4.25 PR/SH TRY-IN KIT FOR PREMIUM/KOHNO REPLY FOR SHELTA IMPLANT D. 50 MM, L. 13 MM ANCHOR PIN COUNTER ANGLE FOR SURGERY 20:1 ROUNDED DRILL D. 40 MM CONICAL DRILL STOP UNLOCKING HOLDER STOP H.13 MM FOR DRILL MOUNTER OUTLINK2 D. 5,00 MM LONG DRILL DIAM. 3,80 MM TAPERED FINAL DRILL UNDERP. STOP H.12 MM FOR DRILL SURGICAL KIT ROUND TIP OSTEOTOME D.90 SCREW ZIRCONIUM ABUTMENT REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 15 MM CONCAVE TIP OSTEOTOME D.20 MOUNTER HAND DRIVER TITANIUM SUPPORT REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 13 MM TEMP. CAP FOR PRE-MADE ABUT TRANSFER 3.80 PR/SH STOP UNLOCKING HANDLE LONG STOP H. 13, D. 4,15 MM SURGICAL SLEEVE FOR ANCHOR PIN SCREW KIT HAND BONE TAP FOR SHELTA HEALING CAP FOR PRE-MADE ABUT SHORT STOP H. 7, D. 4,15 MM LONG PROSTHETIC HAND LONG DRILL DIAM. 2,90 MM TAPERED BONE TAP STOP FOR SHORT DRILL HANDLE FOR D.B.E.SYSTEM BOX FOR PRE-MADE ABUTMENT TRANSFER P.A.D. MILLABLE CRCO ABUTMENT ROUNDED DRILL D. 30 MM EXTRALONG PROSTHETIC HAND PLUGGER AND DEPTH GAUGE HOLDER FOR PREMIUM MOUNTER STOP KEY SHORT DRILL DIAM. 3,00 MM SURG. KIT FOR PREMIUM-SHELTA HAND KNOB FOR DRIVERS, BONE PROSTHETIC ACCESSORIES KIT CASTABLE POST, REP., CR-CO TI POST STRAIGHT ANALOGUE FOR PRAMA IMPLANT CRCO POST ANATOMICAL CRCO POST STRAIGHT NECK POSITION PIN CLUTCH DRILL ABUTMENT TIT. D.12 GUIDED SURGERY PIVOT M-TWO INSTRUMENT EASY MOUNTER SPIRAL DRILL INSERTION INSTRUMENT DIGITAL ANALOGUE DEPTH GAUGE STOP H.5,5 MM FOR DRILL SCREW MOUNTER SCREW MOUNTER PIN STOP H.4,5 MM FOR DRILL STOP H.2,5 MM FOR DRILL MUCOTOME PEEK OSTEOTOME TIP CURVED HANDLE STOP H.1,5 MM FOR DRILL EXTRACTOR SCREW DRILL HANDLE MASTER SLEEVE FINAL CONICAL DRILL STOP H.3,5 MM FOR DRILL CYLINDRICAL DRILL BONE GRAFTING MATERIAL THE GRAFT MOTOR, SURGICAL INSTRUMENT, ACPOWERED Ossix Plus OMNIA NEOMEM ECM COLLAGEN DENTAL WOUND DRESSING IMPLANT ANGLE HANDPIECE PRE-MADE REP. POST STRAIGHT PLAIN ABUTMENT H2 MM PRE-MADE REP. POST ANATOMICAL MILLABLE REP. POST FOR 30GR ANGLED PAD ABUT., H5 MM CASTABLE REP. POST WITH GOLD 15GR ANGLE PRE-MADE POST, REP. TRANSGINGIVAL HEALING CAP H7MM STRAIGHT PAD ABUTMENT, H4 MM PRE-ANGLED REP. MILLABLE POST TRANSGINGIVAL HEALING CAP H5MM 25GR ANGLE PRE-MADE POST, REP. STRAIGHT PAD ABUTMENT, H1.5 MM SIMPLE TEMP. POST PEEK+TIT REP 30GR ANGLED PAD ABUT., H3 MM SIMPLE TEMP. POST TIT. REP. CASTABLE REP. POST WITH CRCO MILLABLE POST, REP. 17GR ANGLED PAD ABUT., H5 MM CAST. NON REP. POST WITH GOLD 17GR ANGLED PAD ABUT., H3 MM PLAIN ABUTMENT H3 MM TRANSGINGIVAL HEALING CAP H3MM STRAIGHT PAD ABUTMENT, H3 MM SIMPLE TEMP. POST TIT. NON REP PLAIN ABUTMENT H4 MM CAST. NON REP. POST WITH CRCO TRANSGINGIVAL HEALING CAP H2MM REMOVAL SCREW KIT PREPARATION DRILLS KIT FOR TEMPORARY BRIDGES FOR B.O.P.T. PREPARATION DRILLS KIT FOR B.O.P.T. DIAMOND BUR PTFE Nonabsorbable Surgical Sutures Premium Implant Systems - Shelta Implant Systems MICRONITI ROTARY ENDOHANDPIECE HEALING ABUTMENT PRAMA WHITE PRAMA WHITE IMPLANT ZIRTI PRE-MADE REP. POST FOR PRAMA PRE-MADE NON REP. POST FOR PRAMA RF WHITE IMPLANT ZIRTI MONOGLYC DENTAL HANDPIECE

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198